Covidien, a medical device manufacturer based in Dublin, Ireland, released the results of its five-year radiofrequency ablation therapy study. The ClosureFast Long-Term European Multi-Center Study was designed to determine the efficacy of radiofrequency ablation therapy for patients suffering from chronic venous insufficiency.
According to a press release by the company, the study was conducted at eight different healthcare centers in Europe. The study utilized Covidien’s ClosureFast ablation catheter for the treatment of superficial venous reflux in the lower limbs of 225 patients. Since some patients received treatment in more than one lower limb, the catheter technology was utilized in 295 operations.
Chronic venous insufficiency (CVI) and varicose veins are both caused by superficial venous reflux. According to information from Covidien, an estimated 30 million patients in the United States suffer from CVI. In some cases, varicose veins can progress to CVI. This can result in skin damage, leg ulcerations and pain.
Mark Turco is the chief medical officer of the vascular therapies division at Covidien. In prepared remarks, he said, "This pivotal study provides substantial long-term data on relevant end-points to help clinicians decide the appropriate treatment for their patients, thus defining Covidien's commitment to a strong foundation of clinical research.”
According to the results of the study, 92 percent of compliant patients had full occlusion of the vein that received treatment. In addition, 95 percent of patients no longer suffered from pathological venous reflux.
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